Mitomycin, ifosfamide and cisplatin in non-small cell lung cancer (NSCLC): A randomised trial of chemotherapy plus radiotherapy versus radiotherapy alone

ISRCTN	ISRCTN56319613
DOI	https://doi.org/10.1186/ISRCTN56319613
ClinicalTrials.gov number	NCT00003240
Secondary identifying numbers	LU3001

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lung (non-small cell) cancer
Intervention	1. Schedule A: Combination chemotherapy, four 3 weekly cycles of mitomycin, ifosfamide and cisplatin (MIC). Followed by radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour. 2. Schedule B: Radiotherapy as decided by the radiotherapist. The total minimum dose should not be less than 40 Gy in fifteen fractions and the field size adequate to encompass the known extent of the tumour.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mitomycin, ifosfamide and cisplatin
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1990
Completion date	01/01/1996

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Age 75 years or under 2. Histologically or cytologically proven non-small cell lung cancer, ie adeno- squamous or large cell carcinoma 3. Clinically or radiologically evaluable disease 4. Inoperable, but clinically limited stage disease 5. WHO performance status of 0-2 6. No previous chemotherapy or radiotherapy 7. No metastatic disease, except ipsilateral stem cell factor (SCF) lymphadenopathy 8. Normal renal function 9. No other previous or concurrent malignancy, except cone biopsied carcinoma in-situ of the cervix and adequately treated basal cell carcinoma of the skin 10. No pleural effusion or symptomatic superior vena cava obstruction 11. No pre-existing severe impairment of lung function likely to prejudice the safe administration of the proposed radiotherapy 12. No indication that protocol treatment would exacerbate a serious pre-existing medical condition
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	01/01/1996

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	interim analysis	01/04/1995		Yes	No
Results article	results	01/10/1999		Yes	No